Compliance Clinical Trial
Official title:
Validity and Reliability of the Turkish Version of the Pectus Carinatum Evaluation Questionnaire for Patients With Pectus Carinatum
NCT number | NCT04783948 |
Other study ID # | 2020-19/09 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 3, 2021 |
Est. completion date | October 18, 2021 |
Verified date | October 2021 |
Source | Acibadem University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Based on the hypothesis that the chest wall was still pliable in adolescence and could be reshaped in a normal position with the external suppressor applied on the chest, a pressure orthosis was started to be used in the pectus carinatum. It is the focus of attention as it is an alternative method to surgery for patients. However, the patient's compliance with the orthosis is difficult. Therefore, in our study, we aimed to investigate the Turkish Validity and Reliability of the Pectus Carinatum Evaluation Questionnaire, which is a questionnaire investigating the compliance with orthosis treatment in patients diagnosed with Pectus Carinatum by the doctor.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 18, 2021 |
Est. primary completion date | May 3, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility | Inclusion Criteria: 1. Patients who have been diagnosed with Pectus Carinatum by a doctor, have an orthosis indication (2 cm above the protrusion level) and who are given the orthosis for the first time 2. Having a correction pressure below 10 pounds per square inch (PSI) in the compression test 3. Between the ages of 10-18, 4. Having dissatisfaction with this defect Exclusion Criteria: 1. Having severe scoliosis (Cobb angle over 20 degrees) 2. Having chronic systemic disease 3. Having a serious psychiatric illness 4. Having complex mixed type pectus deformity |
Country | Name | City | State |
---|---|---|---|
Turkey | Acibadem University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Acibadem University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pectus Carinatum Evaluation Questionnaire | A questionnaire (Pectus Carinatum Evaluation Questionnaire, PCEQ) was developed by Pessanha et al to be applied in the follow-up of Pectus Carinatum patients. The PCEQ was divided into four different sections, allowing a thorough evaluation of compliance, symptoms, social influence and engagement with sports and daily activities. | 15-21 days | |
Secondary | The Pectus Excavatum Evaluation Questionnaire | The Pectus Excavatum Evaluation Questionnaire (PEEQ) was developed and validated by Lawson et al to measure the physical and psychosocial quality-of-life changes after surgical repair of pectus excavatum. Each of the 17 items in the PEEQ is in a Likert scale format, where low scores indicate better outcome. | 15-21 days |
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